The Wall Street Journal [Printer-friendly version] October 13, 2005 COMMENTARY: UNPRINCIPLED PRECAUTION [Rachel's introduction: Professor Gary Marchant seems to be making a career out of trashing foresight and forecaring.] By Gary Marchant [RPR introduction: Professor Gary Marchant of Arizona State University seems to be making a career out of trashing the precautionary principle. We last saw his work in RPR #1. His latest book attacking foresight and forecaring can be purchased here. --RPR editors] Last year, the European Union slipped through a little-known law -- the Physical Agents (Electromagnetic Fields) Directive -- which regulates exposure to electromagnetic fields, including those used for medical diagnostic purposes such as magnetic resonance imaging (MRI) devices. European bureaucrats claim that, because not everything is known about such technologies, their use must be restricted. In Britain, 12 leading scientists and doctors appealed to the Department of Trade and Industry, stating that such restrictions will actually cause more harm than good by exposing patients to X-rays, a relatively more dangerous technology. This quandary -- saving many human lives today with a well-studied technology, versus possibly saving hypothetical future lives because not all risks of the technology are understood -- demonstrates an increasingly contentious issue in the European Union known as the precautionary principle. In its most basic form, the principle suggests that because we don't know everything about a technology, product or process, it is better for regulators and legislators to "err on the side of caution" -- to regulate, restrict or even prohibit technologies, substances and processes unless they are proven "safe." The principle's strongest advocates include EU bureaucrats, academics, NGOs and even some businesses. They tout the fact that Europe leads the world in employing the precautionary principle in policy making. Citing a litany of cases where regulators did not act quickly enough to prevent tragic unexpected consequences, these advocates herald the principle as an innovation in regulatory decision-making. In the coming weeks, the European Parliament will vote on new legislation -- the Reach Directive -- which seeks to register and control at least 30,000 manmade chemical substances. Again driven by the precautionary principle, these substances are presumed guilty until proven innocent. The producer must prove that they are harmless to consumers. Yet it is impossible to prove that a substance, technology or process is "harmless" -- for this is a relative concept. While the notion that it is better to be safe than sorry is intuitively appealing, any rational regulatory decision should take into account the costs of taking action. It certainly makes sense to foresee and avoid harm when the benefits of so doing outweigh the costs, but not when the costs outweigh the benefits. Many modern risk- management systems make great efforts to achieve this balance -- but increasingly this is no longer the case in the EU. The problem with the principle is that it is not actually a principle. There is no single or official version. Swedish philosopher Per Sandin collected 19 varieties. These formulations differ in important details, such as whether and how costs should be considered, whether all risks or only "serious and irreversible" risks raise concerns, and how a product manufacturer can comply with the principle. The principle is inherently imprecise. Precisely because it is so difficult to pin down, it can hardly be used as a coherent basis for laws and regulations, whether in the EU or elsewhere. It is flawed in theory, and it is also flawed in practice. Nowhere is this more evident than in more than 60 legal cases heard in the EU's court system over the past decade. The cases leave little doubt that the principle has become a binding rule of law in the EU -- but judges disagree broadly on its importance and significance. This has led to its selective use, producing extreme, inconsistent and irreconcilable decisions. In only one of the 60 cases -- Artegodan GmbH vs. Commission (which concerned the withdrawal of marketing authorization for certain obesity drugs) -- did a European court attempt to define the precautionary principle and its requirements. The resulting definition seemingly gives regulators carte blanche as to when to deploy, and when to disregard, the principle. The Commission often appears to use the principle where science runs at odds with irrational public fears. Its own Scientific Committee for Animal Nutrition (SCAN) advised that a ban on certain animal antibiotics was not necessary during a period in which further tests were being conducted. Yet, while the tests were occurring, the Commission moved forward and banned the antibiotics. In a truly Orwellian twist, the Court of First Instance primarily relied on SCAN's scientific opinion -- which concluded that there was little or no risk from the antibiotic in question -- to nevertheless ban a product that had been used safely for decades. Recent studies suggest that this use of the precautionary principle may have had the net effect of increasing rather than decreasing human health risks. Judging by these and countless other examples, the power of the precautionary principle lies in its ambiguity: It is politically viable only while it remains nebulous. Nevertheless, the EU courts' advocate general warned in one opinion that, "The precautionary principle has a future only to the extent that, far from opening the door wide to irrationality, it establishes itself as an aspect of the rational management of risks, designed not to achieve zero risk, which everything suggests does not exist." Still, most attempts to pin it down will be met with disdain by vested bureaucratic, ideological, commercial and political interests who benefit from the principle. A reasonable risk-management system prevents unreasonable risks to human health and the environment before they occur. It also recognizes the inherent uncertainty in predicting risks, and the potentially burdensome economic, social and health trade-offs which result from overregulating nonexistent or insignificant risks. It should also be transparent in its methods, and accountable to those who must comply with its demands. Put on trial in Europe's courts, the precautionary principle is guilty of affording discretionary power to regulators, eliminating transparency amongst regulators and undermining some of the most fundamental tenets of democratic decision making. Put into practice widely, its knock-on effects will result in stagnation -- hardly needed in an already ailing Europe. The experience of Europe's courts have demonstrated that its "enlightened" reliance on the precautionary principle is no model for the rest of the world: Put into practice, it causes more harm than good.